# FDA recall Z-1593-2024

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2024-01-31.

## Product

Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay  Catalog Number: MA1567

## Reason for recall

Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and  may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.

## Distribution

US Nationwide distribution in the states of GA, MA, WV including PR.

## Key facts

- **Recall number:** Z-1593-2024
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-31
- **Report date:** 2024-04-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1593-2024

## Citation

> AI Analytics. FDA recall Z-1593-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1593-2024. Source: US FDA. Licensed CC0.

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